Beaver Medical Group

Abstract Across the United States, the high school mascot is a symbol of pride and tradition for students, alumni, and community members. However, efforts to change a traditional mascot, even one that is considered racially offensive, can create conflict and divide stakeholders. Superintendents are responsible for addressing conflict and helping districts manage change in complex systems in ways that both respect tradition and build a culture of care and fairness for all students. This problem of practice features the experiences of Monte Woolstenhulme, a 14-year veteran superintendent of Teton School District 401, a rural district of nearly 2,000 students. Early in his tenure, Superintendent Woolstenhulme unilaterally decided to change the name of Teton’s high school mascot: The Redskins. After a contentious community listening session, the school board indefinitely tabled the proposed mascot name change. Woolstenhulme continued his work in the district, and 6 years later, by vote of the students at Teton High School, the mascot was changed to the Timberwolves. This case study provides an example of ethics in educational leadership and offers a glimpse into how superintendents can manage district change and community conflict, build superintendent and board relations, and lead efforts to respect all cultures and communities.

This study aimed to evaluate discordance, binary classification, and model fit between race-predicted and race-neutral spirometry prediction equations. Spirometry data from 9506 patients (18-95 years old) self-identifying as White, Black, or Hispanic were analyzed, focusing on the lower limit of normal (LLN). Best-fit prediction equations were developed from 3771 patients with normal spirometry, using Bayesian Information Criterion (BIC) to compare models with and without race as a covariate. Results showed that including race as a covariate improved model fit, reducing BIC by at least ten units compared to Race-Neutral equations. Discordance between race-specific and race-neutral equations for detecting airway obstruction and restrictive spirometry patterns ranged from 4% to 13%. Using race-neutral equations resulted in false discovery rates (FDR) of 14% for Hispanics and 45% for Blacks and false negative rates (FNR) of 21% for Hispanics and 27% for Blacks in diagnosing airway obstruction. These findings indicate that removing race as a covariate in spirometry equations increases FDR and FNR, leading to higher misclassification rates. The 4%-13% discordance in interpreting airway obstruction and restrictive patterns has significant clinical implications, underscoring the need for careful consideration in developing spirometry reference equations.

Abstract Background: SPI-2012 is a distinct biologic that uses the innovative, proprietary long-acting protein/peptide discovery technology (LAPSCOVERY™) to enhance the activity of G-CSF. SPI-2012 consists of a novel, modified recombinant human G-CSF conjugated to the Fc fragment of IgG4 via a polyethylene glycol linker to produce a new, more potent, longer-acting G-CSF with a potentially unique distribution to areas rich in Fc receptors. The primary endpoint of this Phase 3 study is to compare the efficacy of a single dose of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer (ESBC) receiving TC chemotherapy, as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1. Key secondary objectives include the comparison of SPI-2012 with pegfilgrastim during Cycle 1 in: Time to Absolute Neutrophil Count (ANC) Recovery; Depth of ANC Nadir and Incidence of Febrile Neutropenia. Safety and pharmacokinetics will also be assessed. Trial Design: This is a randomized, open-label, active-controlled, multicenter study comparing the efficacy and safety of SPI-2012 to pegfilgrastim. Patients (n=506) will be randomized in a 1:1 ratio to receive either SPI-2012 (equivalent to 3.6 mg G-CSF) or pegfilgrastim (equivalent to 6.0 mg G-CSF) once per chemotherapy cycle (up to 4 cycles), approximately 24 hrs after chemotherapy. Eligibility Criteria: This study will enroll histologically confirmed ESBC patients who are eligible to receive adjuvant or neoadjuvant TC chemotherapy and at least 18 years of age, with adequate hematologic, renal and hepatic function. Patients will be excluded if they have active concurrent malignancy or life-threatening disease; a known sensitivity or previous reaction to E. coli derived products or any of the products to be administered during study participation; concurrent adjuvant cancer therapy; locally recurrent/metastatic or contralateral breast cancer; previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development prior to the administration of study drug; bone marrow or hematopoietic stem cell transplant or radiation therapy prior to enrollment or are pregnant or breast-feeding. Statistical Methods: The goal of the study is to demonstrate non-inferiority of SPI-2012 to pegfilgrastim. For the Primary Efficacy Analysis, the mean DSN in Cycle 1 will be compared between the SPI-2012 and pegfilgrastim treatment arms. A 2-sided 95% confidence interval (CI) of the difference between the mean DSN of the SPI-2012 arm and the mean DSN of the pegfilgrastim arm will be calculated using bootstrap resampling with treatment as the only stratification factor. For the Secondary Efficacy Analyses, the results will each be summarized by treatment arm and Cycle. The two-sided 95% CI for the difference between the treatment arms will be calculated. Target Accrual: Approximately 506 pts. Citation Format: Schwartzberg L, Vacirca JL, Hager SJ, Adoo CS, Ibrahim EN, Bhat G, Choi MR, Allen LF, Tedesco KL, Agajanian R. Randomized phase 3 study of a novel, long-acting G-CSF (SPI-2012) versus pegfilgrastim in the management of chemotherapy-induced neutropenia in early-stage breast cancer patients receiving docetaxel and cyclophosphamide (TC) (ADVANCE study). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-02-13.

Adequately recording diastolic heart sounds and systolic time intervals over longer periods is difficult. Thus, information on the circadian variation of these parameters in an ambulatory population is lacking. Moreover, age-related changes in the prevalence of diastolic heart sounds and measurements of systolic time intervals in an asymptomatic population have not been studied in continuous recordings. Diastolic heart sounds and systolic time intervals will have age and circadian variations that reflect known changes in cardiac function due to aging and circadian rhythms. We studied 128 asymptomatic subjects wearing an ambulatory monitor with acoustic cardiography. The recording spanned a mean duration of 14 hours, including sleep. Data were analyzed for the presence of third (S3) and fourth (S4) heart sounds and for systolic time intervals. In these asymptomatic subjects, S3 was significantly more prevalent in those age <40 years than in those age >40 years, and significantly more pronounced during sleep in the younger group. Also, S4 was significantly more prevalent in those age >40 years and significantly more pronounced during sleep in those age >40 years. In contrast, time intervals reflecting systolic function showed less circadian variation and less worsening with age. The nocturnal increase of S4 in the elderly reflects diastolic impairment-likely a result of changes in diastolic filling patterns with increasing age. An S3 after the age of 40 is a relatively uncommon finding and therefore should be a specific sign of cardiac disease. Continuous monitoring of diastolic heart sounds and systolic time intervals is possible using acoustic cardiography.

This study was designed to evaluate the impact of a standardized laparoscopic intracorporeal right colectomy on the short-term outcome of patients with neoplasia. Consecutive patients with histologically proven right colon neoplasia underwent a standardized laparoscopic intracorporeal right colectomy with medial to lateral approach encompassing ten sequential steps: 1) ligation of ileocolic vessels, 2) identification of right ureter, 3) dissection along superior mesenteric vein, 4) division of omentum, 5) division of right branch of middle colic vessels, 6) transection of transverse colon, 7) mobilization of right colon, 8) transection of terminal ileum, 9) ileocolic anastomosis, 10) delivery of specimen. Values were medians (ranges). From July 2002 to June 2005, 111 laparoscopic intracorporeal right colectomies were attempted with a 5.4 percent conversion rate. There were 57 women and 54 men, aged 64.9 (range, 40-85) years, with body mass index of 33 (range, 20-43), American Society of Anesthesiology score of 2 (range, 2-4), 36.9 percent comorbidities, and 37.8 percent previous abdominal surgery. The indication for surgery was cancer in 109 patients. Operative time was 120 (range, 80-185) minutes. Estimated blood loss was 69 (range, 50-600) ml. Overall length of skin incisions was 66 (range, 60-66) mm; 29 (range, 2-41) lymph nodes were harvested. Length of stay was four (range, 2-30) days. Complication rate was 4.5 percent. A standardized laparoscopic intracorporeal right colectomy resulted in a favorable short-term outcome in unselected patients with neoplasia of the right colon.

To examine potential threats to internal and external study validity caused by differential patient withdrawal from a randomized controlled trial evaluating pharmacist management of hypertension, to compare the characteristics of patients who withdrew with those of patients who completed the study, and to identify characteristics that predispose patients to withdraw from hypertension management. Prospective, randomized, comparative study. Network of primary care clinics. Four hundred sixty-three patients with a diagnosis of hypertension and a last documented systolic blood pressure of 160 mm Hg or greater and/or diastolic blood pressure of 100 mm Hg or greater. Patients were randomly allocated to the pharmacist intervention or usual-care (control) group. Those in the pharmacist intervention group were collaboratively managed by a primary care clinical pharmacy specialist and their primary care provider. Patients in the control group received usual care from only their primary care provider. Of the 463 patients, 191 (41%) withdrew from the study after randomization and 272 (59%) completed the study. Patients who withdrew from the pharmacist intervention group were similar to patients who withdrew from the usual-care group with respect to age, sex, insurance status, and chronic conditions. Patients who smoked or had commercial insurance were more likely to withdraw from the study than the other participants. However, multivariate analysis of all variables, when adjusted for the effect of the intervention, revealed that insurance status was the only variable associated with a heightened probability of withdrawal (p=0.002). Although this study had a high withdrawal rate, between-group patient characteristics remained balanced. Therefore, internal validity was preserved, and outcomes from the study groups could be reliably compared. A lack of significant differences between patients who withdrew versus those who completed, with the exception of insurance status, suggests that external validity was not jeopardized.